Many patients with chronic conditions have difficulty adhering to prescribed therapies. In general, the more medications taken and the more times each day that patients must use various therapies, the more likely there will be a medication error. Often patients have co-morbid conditions that interfere with their adherence to medication regimens. These conditions may include diabetes and associated complications such as blindness or lack of mobility, various neurological conditions and dementias, arthritis and associated difficulties in manipulating devices, and other debilitating conditions. The interactions of various co-morbidities can bring additional complexity and dynamism to medication regimens. Cognition also generally declines with age. Consequently, elderly patients may experience difficulty organizing their medications and remembering to take them as prescribed. Frequently, patients do not know what medications they are taking or why these medications are useful. These patients may lose motivation to adhere to their prescribed regimens. Often patients stop medications because they experience adverse side effects. Adjusting the medication dose, or switching to an alternative medication, can often minimize these side effects while maintaining significant health benefits. These problems are widely recognized, but there have been no cost-effective solutions to date.
Several solutions to the above problems have been proposed. One category of devices monitors when the cap of a prescription pill bottle has been removed. This information is stored electronically and may be uploaded to a data network using a remote docking station. This method is convenient for a few medications, but difficult with many medications. In addition, the individual devices are relatively expensive. Aprex's (www.aardex.com) smart pill bottle cap is an example of such a device.
Another category of devices includes vending machine concepts. These devices contain a plurality of medications and dispense them at an appropriate time specified by internal software and hardware systems. Few of these devices have been commercialized since they are relatively expensive to manufacture and have limited capacity for various medications. The reliability of these devices in a remote setting is also questionable. The e-pill MD.2 Monitored Automatic Medication Dispenser (www.epill.com) is an example of such a device, although it only dispenses a single medication container.
A third category of devices uses a tray which is inserted into a portable device. These trays may be filled with medications as needed. The MEDGlider (www.informedix.com) is an example of such a device. This device has limited capacity for patients with chronic conditions. Also, since the medication tray is not identified to the main device, there may be confusion over which tray should be placed in the device. Finally, this devices does not include a medication package that contains all the medications to be taken at a single time. That is, patients using this device must remove each medication sequentially as they are reminded to by systems contained in the main device. This long sequence of taking multiple medications will limit the number of patients willing to use this device to those with relatively simple conditions, good cognition and strong motivation.
A fourth category of medication management devices is an organizer/reminder device. Typically, these devices use small trays or compartments and are self-programmed by patients to remind them to take medications at a specific time. Typically, the patient also fills the device as needed. When patients either self-program or self-fill the device, errors can occur. These errors become more common as the complexity of the medication regimen increases. Conventional organizer/reminder devices do not prevent these kinds of errors. Since these devices do not record medication usage, and are not connected to a support service, they have limited positive effect on medication adherence.
A fifth category of devices includes pill containers which contain radio frequency (RF) tags that are sensed on a platform. An example of such a device is disclosed in commonly-assigned U.S. Pat. No. 6,294,999, incorporated by reference herein. These devices may contain a large number of pill containers on the device, but each pill container is placed individually on the device. This creates some difficulty for the patients using these devices since they have to place a large number of containers randomly on the device; there is also some potential that some containers will be lost. An additional limitation of this approach is the need to fill a large number of medication containers with a number of different medications all taken at a specific time by the patent. These containers must be filled with a high degree of accuracy and precision. In addition, labeling of containers that contain many medications is difficult since the containers may not be large enough to hold a legible label listing required information for each medication in the pill container.
Other commonly-assigned U.S. patents and published international (PCT) applications disclosing related subject matter are listed below. Each of the listed patents and published applications is incorporated by reference herein.
4,731,7264,768,1775,200,8915,642,7315,897,4935,954,6415,997,4766,024,6996,101,4786,102,8556,161,0956,168,563W0 99/18532W0 99/46718W0 00/32098
The prior art does not satisfy the unmet needs for medication adherence as described above. Solutions to these needs form the objects of the present invention.